# K911310: Corometrics 5566AAX Noninvasive Blood Pressure Mod

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems Information Technologies
- Decided: Jun 10, 1991 after 84 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
17 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K964770: Corometrics 120 Series Maternal/Fetal Monitor (1997), 16 descendants of its own
- K991739: Corometrics 120 Series Maternal/Fetal Monitor (1999), 10 descendants of its own
- K082602: Fetal & Maternal Monitor, Model F6, F9 (2008), 6 descendants of its own
- K100797: Fetal Maternal Monitor Model F9 Express and Express (2010), 5 descendants of its own
- K150901: Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express (2015), 2 descendants of its own

## Recalls of this device
- Jun 26, 2006 · Not classified · Z-1240-06: The tip of the catheter may separate from the body during operation.

Source page: https://510kreport.com/device/K911310
Methodology: https://510kreport.com/methodology